Method and articles for treating the sinus system

ABSTRACT

A method of treating a sinus cavity of a subject includes advancing a distal portion of a light source through a drainage pathway of a sinus cavity and into the sinus cavity and visually observing a transdermal light emitted from the light source. A distal portion of a substantially rigid inner guide member of a balloon dilation catheter is advanced into the drainage pathway, the balloon dilation catheter including a movable shaft including a balloon that is slidably mounted on the substantially rigid inner guide member. The movable shaft and balloon are advanced distally over the substantially rigid inner guide member to place a portion of the balloon in the drainage pathway whereby the balloon is inflated.

RELATED APPLICATIONS

This Application is a continuation of U.S. application Ser. No.16/011,397 filed on Jun. 18, 2018, which itself is a continuation ofU.S. application Ser. No. 14/918,468 filed on Oct. 20, 2015, now issuedas U.S. Pat. No. 10,022,525, which is a continuation of U.S. applicationSer. No. 14/468,617 filed on Aug. 26, 2014, now issued as U.S. Pat. No.9,370,650, which is a continuation of U.S. application Ser. No.13/277,885 filed on Oct. 20, 2011, now U.S. Pat. No. 8,834,513, whichitself is a continuation-in-part of U.S. application Ser. No. 12/479,521filed on Jun. 5, 2009, now issued as U.S. Pat. No. 8,282,667, and claimspriority to U.S. Provisional Patent Application No. 61/405,035 filed onOct. 20, 2010. Priority is claimed pursuant to 35 U.S.C. §§ 119 and 120.The above-noted Patent Applications are incorporated by reference as ifset forth fully herein.

FIELD OF THE INVENTION

The field of the invention relates to balloon dilation devices, devicesfor illuminating nasal and sinus cavities, and methods for the treatmentof sinusitis.

BACKGROUND OF THE INVENTION

Sinusitis is a condition affecting over 35 million Americans, andsimilarly large populations in the rest of the developed world.Sinusitis occurs when one or more of the four paired sinus cavities(i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed, orotherwise has compromised drainage. Normally the sinus cavities, each ofwhich are lined by mucosa, produce mucous which is then moved by beatingcilia from the sinus cavity out to the nasal cavity and down the throat.The combined sinuses produce approximately one liter of mucous daily, sothe effective transport of this mucous is important to sinus health.

Each sinus cavity has a drainage pathway or outflow tract opening intothe nasal passage. This drainage passageway can include an ostium, aswell as a “transition space” in the region of the ostia, such as the“frontal recess,” in the case of the frontal sinus, or an “ethmoidalinfundibulum,” in the case of the maxillary sinus. When the mucosa ofone or more of the ostia or regions near the ostia become inflamed, theegress of mucous is interrupted, setting the stage for an infectionand/or inflammation of the sinus cavity, i.e., sinusitis. Though manyinstances of sinusitis may be treatable with appropriate medicates, insome cases sinusitis persists for months or more, a condition calledchronic sinusitis, and may not respond to medical therapy. Some patientsare also prone to multiple episodes of sinusitis in a given period oftime, a condition called recurrent sinusitis.

Balloon dilation has been applied to treat constricted sinus passagewaysfor the treatment of sinusitis. These balloon dilation devices typicallyinvolve the use of an inflatable balloon located at the distal end of acatheter such as a balloon catheter. Generally, the inflatable balloonis inserted into the constricted sinus passageway in a deflated state.The balloon is then expanded to open or reduce the degree ofconstriction in the sinus passageway being treated to facilitate bettersinus drainage and ventilation.

Exemplary devices and methods particularly suited for the dilation ofanatomic structures associated with the maxillary and anterior ethmoidsinuses are disclosed, for example, in U.S. Pat. No. 7,520,876 and U.S.Patent Application Publication No. 2008-0172033. Other systems have beendescribed for the treatment of various other sinuses including thefrontal sinus. For example, U.S. Patent Application Publication No.2008-0097295 discloses a frontal sinus guide catheter (FIG. 6B) andmethod of treating the frontal sinuses (e.g., FIGS. 8B-8C). U.S. PatentApplication Publication No. 2008-0125626 discloses another guide device(e.g., FIGS. 10C and 10C′) for transnasal access to the frontal sinusesfor treatment.

SUMMARY OF THE INVENTION

In a first embodiment of the invention, a balloon dilation catheterincludes a substantially rigid inner guide member and a movable shaftcoupled to a balloon that is slidably mounted on the substantially rigidinner guide member. To treat a drainage pathway of a sinus cavity (e.g.,frontal sinus cavity) of a subject using the balloon dilation catheter,the substantially rigid inner guide member is advanced into a drainagepathway of the subject via a nasal passageway. The shaft and balloon arethen advanced in a distal direction over the substantially rigid innerguide member to place the balloon in the drainage pathway. This enablesthe balloon to track over the inner guide member. The balloon isinflated to expand or otherwise remodel the drainage pathway. Where thesinus cavity is the frontal sinus cavity the drainage pathway is thefrontal recess.

In another aspect of the invention, a device for dilating the outflowtract of a sinus cavity includes a substantially rigid inner guidemember having a proximal end and a distal end and a shaft coupled to aballoon, the shaft having a first lumen along at least a portion thereofcontaining the substantially rigid inner guide member, the shaft havinga second lumen operatively coupled to the interior of the balloon. Ahandle is disposed along a proximal portion of the substantially rigidinner guide member, the handle including a moveable knob operativelycoupled to the shaft, wherein distal advancement of the knob advancesthe shaft and balloon over the substantially rigid inner guide in adistal direction.

In further aspects of the invention, taught herein are methods oftreating a sinus cavity of a subject. In some embodiments the methodincludes advancing a distal portion of a light source through a drainagepathway of a frontal sinus cavity of a subject and into the frontalsinus cavity; visually observing a transdermal light emitted from thedistal portion of the light source in the frontal sinus cavity;advancing a distal portion of a substantially rigid inner guide memberof a balloon dilation catheter into the drainage pathway of the frontalsinus cavity, the balloon dilation catheter including a movable shaftslidably mounted on the substantially rigid inner guide member, themovable shaft including a balloon; advancing the movable shaft andballoon distally over the substantially rigid inner guide member toplace a portion of the balloon in the drainage pathway; and inflatingthe balloon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a balloon dilation catheteraccording to one embodiment.

FIG. 2A illustrates a side view of a balloon dilation catheter ofFIG. 1. The advancer knob is illustrated in the retracted, proximalposition.

FIG. 2B illustrates a cross-sectional view of the balloon dilationcatheter of FIG. 2A.

FIG. 3A illustrates a side view of a balloon dilation catheter ofFIG. 1. The advancer knob is illustrated in the advanced, distalposition.

FIG. 3B illustrates a cross-sectional view of the balloon dilationcatheter of FIG. 3A.

FIG. 4 is a cross-sectional view of the handle portion (dashed lineportion) of FIG. 3B.

FIG. 5A is a cross-sectional view of the balloon dilation catheter takenalong the line A-A′ of FIG. 2B.

FIG. 5B is a cross-sectional view of the balloon dilation catheter takenalong the line B-B′ of FIG. 4.

FIG. 6A is a side view of an inner guide member according to oneembodiment.

FIG. 6B is a side view of an inner guide member according to anotherembodiment.

FIG. 6C is a side view of an inner guide member according to anotherembodiment.

FIG. 7 illustrates a perspective view of a balloon dilation catheteraccording to another embodiment.

FIG. 8 illustrates a cross-sectional view of the frontal sinus of asubject with the inner guide member of the balloon dilation catheterbeing advanced into the subject's frontal recess.

FIG. 9 illustrates a cross-sectional view of the frontal sinus of asubject with the inner guide member of the balloon dilation catheterbeing positioned in the subject's frontal recess. A guide wire is shownadvanced through the catheter and into the subject's frontal sinuscavity.

FIG. 10 illustrates a cross-sectional view of the frontal sinus of asubject with the balloon (in a deflated state) and shaft being advancedinto the subject's frontal recess.

FIG. 11 illustrates a cross-sectional view of the frontal sinus of asubject with the balloon of FIG. 10 in an inflated state to therebywiden and remodel the frontal recess.

FIG. 12 illustrates a cross-sectional view of the frontal sinus of asubject after the frontal sinus has been widened and the ballooninflation catheter withdrawn.

FIG. 13 illustrates a perspective view of a lighted probe device.

FIG. 14 illustrates a top view of a lighted probe device.

FIG. 15 illustrates a side view of a lighted probe device.

FIG. 16 illustrates a cross-sectional view of the lighted probe devicetaken along line A-A of FIG. 14.

FIG. 17 illustrates an exploded side view of a light source.

FIG. 18 illustrates a cross-sectional side view of a connector.

FIG. 19A illustrates a perspective view of a guide catheter.

FIG. 19B illustrates a photographic view of a removable light-fiberlight source and tuohy-borst connector.

FIG. 19C illustrate a perspective side view of portions of a removablelight-fiber light source.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

FIG. 1 illustrates one embodiment of a balloon dilation catheter 10 thatis particularly suited for treatment of the outflow tract (frontal sinusostium and frontal recess) of the frontal sinus of a subject. Theballoon dilation catheter 10 includes a handle 12 that is configured tobe gripped or otherwise manipulated by the operator. An elongate-shapedinner guide member 14 extends longitudinally from the handle 12 in adistal direction. The inner guide member 14 is formed of a suitablyrigid material such as stainless steel hypotube. The inner guide member14 projects or otherwise extends distally from the handle 12 for apre-determined distance. The inner guide member 14 may be pre-shaped tohave a curved distal portion 16 as is illustrated in FIGS. 1, 2A, 2B,3A, 3B, 6A, 6B, 7, 8, and 9. For example, the nature and degree of thecurved distal portion 16 may be configured to match with the frontalsinus outflow tract or frontal recess.

Alternatively, the inner guide member 14 may have some degree ofmalleability such that the user may bend or impart some desired shape orconfiguration to the distal end of the inner guide member 14. Asexplained herein in more detail, the inner guide member 14 may includean optional lumen 18 (best illustrated in FIG. 5A) that extends thelength of the inner guide member 14. In particular, the inner guidemember 14 and the contained lumen 18 may extend from a distal end 20 toa proximal end 21 (best seen in FIGS. 2B and 3B) that interfaces with asealed arrangement with a port 22 disposed at a proximal end 24 of thehandle 12. The port 22 may be configured with a conventional interfacesuch as a Luer connector. The port 22 may be used as an aspiration portor a delivery port for fluids and/or medicaments, or for introduction ofa guide wire.

Still referring to FIG. 1, a shaft 30 is mounted about the periphery ofthe inner guide member 14. In particular, the shaft 30 is dimensioned toslide over the inner guide member 14 in response to actuation of anadvancer knob 32 located on the handle 12. The advancer knob 32 ismoveable along a slot 42 contained in a surface of the handle 12. Adistal end 34 of the shaft 30 includes a balloon 36 that is configuredto be selectively inflated or deflated as explained herein. During use,the inner guide member 14 is manipulated and advanced across or into theanatomical space of interest. The shaft 30 as well as the attachedballoon 36 is illustrated in a retracted state in FIG. 1. While FIG. 1illustrates the balloon 36 in an inflated state for better illustration,the balloon 36 is typically in a deflated state when the shaft 30 is inthe proximal position as illustrated in FIGS. 2A and 2B. After the innerguide member 14 is properly positioned, the user actuates the advancerknob 32 by sliding the same in the distal direction which, in turn,advances the shaft 30 and balloon 36 in a distal direction over thepre-placed inner guide member 14. Once the balloon 36 is properlyplaced, the balloon 36 is inflated. Inflation of the balloon 36 isaccomplished using an inflation device (not shown) that is coupled to aport 38 located at the proximal end 24 of the handle 12. One exemplaryinflation device that may be used in connection with the balloondilation catheter 10 is described in U.S. patent application Ser. No.12/372,691, which was filed on 17 Feb. 2009, published as U.S. Pat. App.Pub. No. 2010/0211007, and is incorporated by reference as if set forthfully herein. Of course, other inflation devices may also be used. Aninflation lumen 48 contained within the shaft 30 (described in moredetail below), fluidically couples the port 38 to an interior portion ofthe balloon 36.

Still referring to FIG. 1, an optional support member 40 in the form ofa tube may be located about the external periphery of a portion of theshaft 30 to impart further stiffness to the balloon dilation catheter10. The particular length of the support member 40 may vary depending onthe application and may extend along some or all or the shaft 30. Thesupport member 40 may be made of a metallic material such as stainlesssteel hypotube that is secured to the shaft 30. The support member 40may be welded or bonded along a length of the shaft 30. Generally, thesupport member 40 does not cover the helical portion (described indetail below) of the shaft 30 that is contained within the handle 12.

FIGS. 2A and 2B illustrate, respectively, side and cross-sectional viewsof the balloon dilation catheter 10 with the advancer knob 32 and thusballoon 36 in the proximal position. In actual use, as explained herein,the balloon 36 is typically in a deflated state when the advancer knob32 is the proximal position as illustrated in FIGS. 2A and 2B. As bestseen in FIG. 1, the advancer knob 32 is slidably disposed along a lengthof the handle 12 inside a slot 42. The advancer knob 32 is thus able toslide back and forth in the distal/proximal direction along the lengthof the slot 42. The slot 42 may incorporate a stop or the like (notshown) to prevent the balloon 36 from being advance too far along thelength of the inner guide member 14. The length of the slot 42 may bevaried in different devices to adjust the length at which the balloon 36may be advanced. Generally, the slot 42 has a length within the range ofabout 1 inch to about 2 inches although other dimensions may fall withinthe scope of the invention.

As seen in FIG. 2B, the advancer knob 32 may be directly coupled to thesupport member 40 that is mounted on the shaft 30. Alternatively, theadvancer knob 32 may be coupled directly to the shaft 30. The advancerknob 32 may be configured or otherwise shaped to enable a finger of theuser (e.g., index finger or thumb) to easily advance or retract the knob32 along the slot 42 contained in the handle 12.

FIGS. 3A and 3B illustrate, respectively, side and cross-sectional viewsof the balloon dilation catheter 10 with the advancer knob 32 and thusballoon 36 in the distal position. Thus, unlike the configurations ofFIGS. 2A and 2B, the advancer knob 32 is located at or near the distalend 26 of the handle 12. Advancement of the advancer knob 32 also slidesthe shaft 30 and attached balloon 36 in a distal direction (arrow A inFIG. 3A) along the inner guide member 14. The balloon 36 thus ispositioned at or adjacent to the distal end 20 of the inner guide member14. The balloon dilation catheter 10 may be designed such that theadvancer knob 32 may be positioned at either the proximal or distalextremes as illustrated in FIGS. 2A, 2B, 3A, 3B. Alternatively, theadvancer knob 32 may be positioned somewhere in between the twoextremes. For example, the optimal position of the balloon 36 may beaccomplished by sliding the advancer knob 32 some fraction (e.g., ¾) ofthe full distance of the slot 42.

Referring to FIGS. 2B and 3B, the inner guide member 14 of the balloondilation catheter 10 extends from a distal end 20 to a proximal end 21that terminates in a sealed interface with a port 22 disposed at aproximal end 24 of the handle 12. The inner guide member 14 optionallyincludes a lumen 18 disposed therein that may be used to provideaspiration functionality via an aspiration device (not shown) coupled toport 22. Aspiration functionality permits the removal of blood and othersecretions. This makes it easier to visualize the placement of theballoon dilation catheter 10. The inner guide member 14 isadvantageously rigid to enable the balloon dilation catheter 10 to bepositioned without the need of a separate guiding catheter or guide wirein most, if not all, instances.

The inner guide member 14 may have a length of about 7 inches to about11 inches from the distal end 20 to the proximal end 21 when loaded intothe handle 12, although other dimensions may be used. The inner guidemember 14 may be formed from stainless steel hypotube having an innerdiameter in the range of about 0.019 inch to about 0.050 inch, and morepreferably between about 0.036 inch and 0.040 inch, with a wallthickness within the range of about 0.005 inch to about 0.020 inch, andmore preferably between about 0.008 inch to about 0.012 inch. The curveddistal portion 16 of the inner guide member 14 may be formed right tothe distal end 20 and may have a radius of curvature of about 0.25 inchto about 1.5 inch, and more preferably about 0.75 to about 1.25 inch.

The length of the inner guide member 14 that projects distally from thedistal-most portion of the balloon 36 is about 0.5 inch to about 2.0inch, and more preferably, about 0.8 inch to about 1.2 inch when theballoon 36 is in the fully retracted state (e.g., illustrated in FIGS.2A and 2B). As seen in FIGS. 1, 2A, 2B, 3A, 3B, 6A-6C, 7-11, the distalend 20 of the inner guide member 14 may incorporate an optional bulboustip 44 in order to make the distal end 20 more atraumatic. The bulboustip 44 further serves to limit forward movement of the balloon 36 andattached shaft 30 when they are advanced distally. The outer diameter ofthe tip 44 is preferably between about 1 mm and about 3 mm.

The balloon 36 is mounted on the shaft 30 so as to form a fluidic sealbetween the two components. The balloon 36 may be bonded to the shaftusing a weld, adhesive, or the like. Alternately, the balloon 36 may besecured to the shaft using a mechanical connection. Generally, anytechnique known to those skilled in the art may be used to secure to theballoon 36 to the shaft 30. Given that the balloon 36 is secureddirectly to the shaft 30, both structures are slidably mounted over theinner guide member 14. The balloon 36 generally takes on acylindrical-shape when inflated. While not limited to specificdimensions, the inflated balloon 36 has a diameter within the range ofabout 3 mm to about 9 mm, and more preferably a diameter within therange of about 5 to about 7 mm when inflated. The length of the balloon36 may generally fall within the range of about 10 mm to 25 mm althoughother lengths may be used. Both the shaft 30 and the balloon 36 arepreferably formed of high strength but flexible polymeric materials suchas polyamides (e.g., Nylon), PEBAX or the like. The balloon 36 may be“blow molded” to a relatively thin wall thickness, and capable ofholding relatively high pressures from about 6 atmospheres to about 20atmospheres of inflation pressure. The balloon 36 is inflated using afluid which is typically a liquid such as water or saline.

Referring now to FIG. 4, a magnified, cross-sectional view of a portionof the handle 12 is illustrated. At the proximal end 24 of the handle 12are located ports 22, 38. The port 22 may be configured with aconventional interface such as a Luer connector or any other connectorknown to those skilled in the art. The port 22 may be integrally formedwith the handle 12 or, alternatively, the port 22 may be a separatestructure that is secured to the handle 12 during assembly. As seen inFIG. 4, the proximal end 21 of the inner guide member 14 forms a sealingarrangement with the port 22. As explained herein, the port 22 may beused as an aspiration port or a delivery port for fluids and/ormedicaments.

FIG. 4 also illustrates port 38 which may be constructed in the same orsimilar manner as port 22 as described above. The port 38 is fluidicallycoupled to the inflation lumen 48 in the shaft 30. In this regard,inflation fluid from an inflation device (not shown) is able to passthrough the port 38 and into the inflation lumen 48 of the shaft 30. Theport 38 may be configured with a conventional interface such as a Luerconnector. The fluid then is able to travel along the length of theshaft 30 via the lumen 48 where the fluid enters the interior of theballoon 36. The inflation fluid is thus able to inflate the balloon 36upon actuation of the inflation device.

As best seen in FIG. 4, a portion of the handle 12 includes a recessedregion 50 that receives both the inner guide member 14 and the shaft 30.In the recessed region 50 of the handle 12, the shaft 30 is helicallywrapped around the outer periphery of the inner guide member 14 forminga helical portion 52. The helical portion 52 facilitates the distaladvancement and proximal retraction of the shaft 30 and attached balloon36 along the inner guide member 14 yet still maintains fluidcommunication with the port 38. The helical portion 52 of the shaft 30,which is located proximal to the advancer knob 32 is in the shape of ahelix that wraps around the inner guide member 14 and is configured toelongate and contract upon movement of the advancer knob 32. FIG. 4illustrates the state of the helical portion 52 after the advancer knob32 has been advanced distally. Thus, in the extended state, the lengthof the helical portion 52 traverses much if not all of the recessedregion 50. Contrast this with FIG. 2B which illustrates the helicalportion 52 compressed to the proximal portion of the recessed region 50because the advancer knob 32 is the in proximal position. Thus, thehelical portion 52 is thus able to expand or compress much in the waythat a spring does in response to a tensile or compressive load. One orboth of the inner guide member 14 and the helical portion 52 of theshaft 30 may be optionally coated or lined with a lubricious coating toprevent the contact surfaces from any unwanted frictional binding or thelike.

The helical portion 52 of the shaft 30 may be formed by “skiving” away aportion of the shaft 30. FIG. 5A illustrates a cross-sectional view ofthe shaft 30, inner support guide 14, and support member 40 along theline A-A′ of FIG. 2B. As seen in FIG. 2B, this area is distal to wherethe helical portion 52 of the shaft 30 is located. Referring now to FIG.5A, the shaft 30 includes a rider lumen 54 that is dimensioned to have adiameter that is slightly larger than the outer diameter of the innersupport guide 14. The rider lumen 54 thus enables the shaft 30 toadvance and retract over the inner support guide 14 in a close-fitarrangement. The outer diameter of the shaft 30 may generally fallwithin the range of about 0.050 inch to about 0.110 inch or within therange of about 0.070 inch to about 0.100 inch. One or both of theexterior surface of the inner guide member 14 and the interior surfaceof the rider lumen 54 may be optionally coated with a lubricious coatingto reduce frictional contact forces. FIG. 5B illustrates across-sectional view of the inner support guide 14 and the helicalportion 52 of the shaft 30 taken along the line B-B′ of FIG. 4. As seenin FIG. 5B, a portion of the shaft 30 that includes the rider lumen 54is skived away. The result is that a single lumen (inflation lumen 48)remains in the shaft 30 that is helically wrapped about the innersupport guide 14.

FIGS. 6A-6C illustrate various embodiments of an inner guide member 14.The inner guide member 14 may have a variety of shapes andconfigurations depending on the particular application or patient. Thedifferent shapes of the inner guide member 14 may be factory-formed in aparticular shape and offered as a different model as fully assembled or,alternatively, the inner guide member 14 may be replaceable or modularelements that could slide inside the rider lumen 54 and inserted intothe port 22 in a press-fit type sealing arrangement. In yet anotheralternative, the shapes could represent desirable shapes that amalleable inner guide member 14 could be formed into by the user tobetter fit a particular application or subject's anatomy.

FIG. 6A illustrates an inner guide member 14 that includes a curveddistal portion 16 that terminates in a straight segment 46. In theembodiment of FIG. 6A, the curve in the curved distal portion 16 ispronounced and turns back on itself in the shape of a “U” in which thedistal end 20 turns back in retrograde fashion. This embodiment may beuseful to treat hard to reach ostia or other structures, e.g., themaxillary ostium or the infundibulum via a transnasal route, if thenasal anatomy will allow for a transnasal approach. While FIG. 6Aillustrates a “U” shaped curve, other degrees of curvature arecontemplated. FIG. 6B illustrates an inner guide member 14 according toanother embodiment. In this embodiment, the curved distal portion 16also terminates in a straight segment 46 although the radius ofcurvature is less pronounced. In this embodiment, the straight segment46 may have a length within the range of about 8 mm to about 10 mmalthough other lengths may be used. It is believed that this embodimentis particularly suited for most frontal recess anatomy. FIG. 6Cillustrates an embodiment in which the inner guide member 14 issubstantially straight. This later embodiment may be particularly suitedfor treating the sphenoids of the subject, or straightforward frontalrecess anatomy.

FIG. 7 illustrates a balloon dilation catheter 10 according to anotherembodiment. In this embodiment, a tracking element 60 is located on thehandle 12 of the balloon dilation catheter 10. The tracking element 60may include an antenna, transmitter, optical reflectors, or the likethat communicates a wireless signal that is then received and processedto determine the orientation and/or positioning of the balloon dilationcatheter 10. In certain embodiments, more than one tracking element 60may be disposed on the balloon dilation catheter 10. Data regarding theorientation and/or positioning of the balloon dilation catheter 10 maythen be processed and displayed on the display for viewing by thephysician. For example, image guided surgery is becoming increasinglycommonplace, permitting physicians to review real time actual or virtualimages of a particular device within a subject during a surgicalprocedure.

For example, U.S. Pat. Nos. 5,391,199 and 5,443,489, which areincorporated by reference, describe a system wherein coordinates of anintrabody probe are determined using one or more field sensors such as,Hall effect devices, coils, or antennas that are carried on the probe.U.S. Patent Application Publication No. 2002-0065455, which is alsoincorporated by reference, describes a system that is capable ofgenerating a six-dimensional position and orientation representation ofthe tip of a catheter using a combination of sensor and radiation coils.U.S. Patent Application Publication No. 2008-0269596, which is alsoincorporated by reference, describes yet another monitoring system thathas particular applications in orthopedic procedures. Commercial systemssuch as the LANDMARX Element (Medtronic Xomed Products, Inc.,Jacksonville, Fla.) are available for use in conjunction with ENTprocedures.

In the embodiment of FIG. 7, the tracking element 60 permits accuratetracking of the distal end 20 of the balloon dilation catheter 10 suchthat an image of distal portion of the balloon dilation catheter 10 maybe superimposed on a patient's anatomical imagery. For example, apreviously conducted computed tomography (CT) scan of the patient may beused to generate a visual image of the patient's anatomical regions ofinterest. Based on the location of the tracking element 60, an imageguided surgery (IGS) system can then superimpose an image of the balloondilation catheter 10 onto the image to better enable the physician tomanipulate and orient the balloon dilation catheter 10.

Other commercial systems may also be used in connection with the balloondilation catheter 10 illustrated in FIG. 7. For example, the INSTATRAK3500 Plus—ENT from GE Healthcare, Chalfont St. Giles, United Kingdom maybe integrated and/or used with the balloon dilation catheter 10. The useof CT guidance to position the balloon dilation catheter 10 is preferredbecause the device may be positioned by the operator with just a singlehand, while viewing the CT image interface (e.g., display) at the sametime the handle 12 is manipulated. Optionally, the balloon dilationcatheter 10 may be initially positioned using an endoscope or othervisualization tool. For instance, a conventional “Hopkins rod” endoscope(not shown) may be manipulated alongside the balloon dilation catheter10 to aid in placement.

FIGS. 8-12 illustrate various cross-sectional views (sagittal plane) ofthe frontal sinus of a subject undergoing treatment with a balloondilation catheter 10. The cross-sectional views illustrate the nasalpassageway 100, the frontal recess 102, and the frontal sinus cavity104. Referring to FIG. 8, the balloon dilation catheter 10 is insertedinto the nasal passageway 100 with the advancer knob 32 in the retractedposition (e.g., as illustrated in FIG. 1, 2A, 2B) such that the shaft 30and balloon 36 are also retracted proximally. In addition, the balloon36 is in a deflated state as seen in FIG. 8. The curved portion 16 ofthe inner guide member 14 is then positioned within the frontal recess102 of the subject as seen in FIG. 8. This positioning of the innerguide member 14 may be accomplished under endoscopic visualization usinga conventional endoscope such as a Hopkins rod-type endoscope that ispositioned alongside the balloon dilation catheter 10. Alternatively,the inner guide member 14 may be positioned using IGS techniques thattrack the position of the balloon dilation catheter 10 using one or moretracking elements 60 as illustrated, for instance, in the embodiment ofFIG. 7. For instance, the inner guide member 14 may be advanced underguidance from CT imaging.

Referring now to FIG. 9, confirmation of accurate positioning of theinner guide member 14 within the frontal recess 102 may be accomplishedby placement of a fluoroscopically visible guide wire 64 through thelumen 18 of the inner guide member 14. The guide wire 64 may be insertedinto the lumen 18 via the port 22. Under fluoroscopic visualization, theguide wire 64 can be seen to advance into the frontal sinus cavity 104once the inner guide member 14 is positioned properly within the frontalrecess 102. If the guide wire 64 does not advance into the frontal sinuscavity 104, the balloon dilation catheter 10 is re-positioned andconfirmation is subsequently attempted. As an alternative to afluoroscopically visible guide wire 64, the guide wire 64 could be alight emitting guide wire such as that disclosed in U.S. PatentApplication Publication No. 2007-0249896, which is incorporated byreference herein. Of course, the guide wire 64 is optional as the innerguide member 14 may be placed without the aid or need for the same.Alternatively, the guide wire 64 could be positioned in the frontalsinus initially, prior to placement of the balloon catheter 10.

Now referring to FIG. 10, once the curved portion 16 of the inner guidemember 14 is properly positioned, the advancer knob 32 is advanced inthe distal direction (arrow A of FIG. 3A) thereby advancing the shaft 30and attached balloon 36 into the frontal recess 102. This is illustratedin FIG. 10. After the balloon 36 is positioned in the frontal recess102, the balloon 36 is inflated as illustrated in FIG. 11. Inflation isaccomplished by coupling an inflation device (not shown) to the port 38.The inflation device may include a syringe or the like that is depressedto infuse a fluid into the inflation lumen 48 which then passes into theinterior of the balloon 36 to effectuate expansion of the balloon 36 tothe state illustrated in FIG. 11. Pressures typically used to accomplishwidening or remodeling of the frontal recess 102 are within the range ofabout 3 atmospheres to about 12 atmospheres. The balloon 36 may beinflated only a single time or, alternatively, the balloon 36 may beinflated, deflated, and inflated again a plurality of times in order toachieve the desired degree of widening. Each inflation step may beperformed after positioning the balloon 36 in a different positionwithin the frontal recess 102.

After the frontal recess 102 has been widened or otherwise remodeled,the balloon 36 is deflated and removed as illustrated in FIG. 12. Thewidened frontal recess 102 illustrated in FIG. 12 is believed to restorethe drainage and aeration function and health of the frontal sinuscavity 104. Deflation of the balloon 36 is accomplished by reducing thefluid pressure within the interior of the balloon 36. For example, theplunger of a syringe or the like that is fluidically coupled to the port38 may be withdrawn to remove fluid from the interior of the balloon 36.The balloon dilation catheter 10 can then be withdrawn proximally fromthe nasal passageway 100.

In certain patients, treatment of one or both frontal sinuses 104 asdescribed above may be adequate. In other patients, additional sinusesmay need to be treated, particularly the maxillary and/or anteriorethmoid sinuses. In such patients, a combination procedure may be wellsuited. The maxillary and/or anterior ethmoid sinuses can be treatedwith a system such as described in U.S. Pat. No. 7,520,876 and U.S.Patent Application Publication No. 2008-0172033, commercially availableas the FinESS system by Entellus Medical, Inc. of Maple Grove, Minn.Alternatively, other sinuses could be treated more conventionally usingsurgical techniques such as, for instance, functional endoscopic sinussurgery (FESS).

Also, the sphenoid and/or maxillary sinus outflow tracts could bedilated with the embodiment of the balloon catheter 10 described above.It is also contemplated that the balloon catheter 10, particularly theembodiment of FIG. 7 with a suitable IGS device is incorporated, andwith an appropriate shape for the inner support member 14, preferablystraight as illustrated in FIG. 6C, could be used to dilate themaxillary sinus outflow tract via the canine fossa route. Suitableaccess tools are described in co-pending U.S. patent application Ser.No. 12/038,719, which was published as U.S. Patent Publication2009-0216196 and is incorporated by reference herein. This could beperformed without need for additional endoscopic visualization,permitting treatment through a relatively small diameter accesspassageway into the sinus cavity in the region of the canine fossa. Asmall endoscope (not shown) could be utilized, if desired, through thelumen 18 of the inner support member 14 to further aid in visualizationof the maxillary sinus outflow tract.

In some embodiments, the invention includes the use of a light source tohelp a practitioner identify portions of, or confirm a location within,a sinus cavity or sinus cavity drainage pathway. For example, in someembodiments, a distal portion of a lighted instrument (e.g., a lightedguidewire, a lighted endoscope, or a lighted probe) is inserted into asubject via a transnasal route and directed into a space or body lumenthat a practitioner suspects is a part of the frontal drainage pathwaythat leads to a frontal sinus cavity. The practitioner directs thelighted distal end of the instrument into the suspected pathway andgently advances the instrument further into the body lumen. If the lumenleads to a frontal sinus cavity, the light from the distal tip willtravel through the bone and tissue walls of the cavity and provide atransdermal or transcutaneous illumination pattern visible to thepractitioner. In this way, the practitioner can confirm that thesuspected body lumen is a part of the frontal drainage pathway and doesin fact lead to a frontal sinus cavity. Manipulation of the instrument(e.g., rotation) will move the illumination pattern, further confirmingthe positioning the instrument in the frontal recess. Once confirmed aspart of the drainage pathway, the practitioner can use the otherembodiments of this invention discussed above to dilate all or parts ofthe pathway. Typically, the lighted instrument would be removed from thefrontal recess prior to the placement of any embodiment of the inventionused to dilate all or parts of the pathway.

In another example, in some embodiments of the invention, a distalportion of a lighted instrument is used to confirm that a given locationis within the maxillary sinus cavity. The practitioner directs thelighted distal end of the instrument to the location and looks for avisible transdermal or transcutaneous illumination pattern (e.g., anillumination pattern on the roof of the mouth or through the skin nearthe cheekbone). Once the pattern is observed, the practitioner thenknows the given location is within the maxillary sinus cavity. If thepattern is not observed, the practitioner then knows the given locationis unlikely to be within the maxillary sinus cavity.

In some embodiments, the lighted instrument is a lighted probe, such asdevice 1300 as illustrated in FIGS. 13-16. FIG. 13 illustrates aperspective view of the entire length of device 1300, while FIGS. 14 and15 illustrate top and side views of device 1300, respectively. FIG. 16illustrates a cut-away side view of device 1300 along lines C-C of FIG.14.

Lighted probe device 1300 includes a handle portion 1302 forming aproximal portion of device 1300. Handle portion 1302 is configured to begripped or otherwise manipulated by the operator. Attached to handleportion 1302 is an elongate-shaped probe member 1304 formed from asuitably rigid material such as a stainless steel hypotube. Probe member1304 projects or otherwise extends distally from handle 1302. Probemember 1304 is pre-shaped to have a curved distal portion 1306. Thenature and degree of curvature of probe member 1304 can be configured tomatch with the frontal sinus outflow tract or frontal recess. In someembodiments, probe member 1304 has some degree of malleability such thata user may bend or impart some desired shape or configuration to thedistal end of probe member 1304.

Device 1300 defines a light-fiber bundle lumen 1312 that extends alongits length, from proximal end 1308 to distal tip 1310. Lumen 1312contains a light-fiber bundle that, during use, directs light from alight source connected at proximal end 1308 and out through distal tip1310 of device 1300. In some embodiments, lumen 1312 contains a singlelight-fiber (e.g., a 30 micron 0.44 NA illumination fiber or a 0.55-0.66NA light fiber) while in other embodiment lumen 1312 contains multiplelight-fibers. The light fiber may, for example, be able to conduct alight powerful enough to produce a 15,000 lux or greater illuminance atdistal tip 1310.

In some embodiments, the light-fiber or fiber bundle may be adhered tothe inside walls of lumen 1312 using an epoxy (e.g., EP42HT-CLEARavailable from Master Bond, Inc. of Hackensack, N.J.). In otherembodiments, the light-fiber or fiber bundle may be removably insertedor removably secured within lumen 1312 such that the light-fiber orfiber bundle can be removed from device 1300 at some point during use.For example, during use, a practitioner of the invention can insert thelight fiber or fiber bundle into lumen 1312, use the lighted probedevice to identify portions of the sinus cavity or sinus cavity drainagepathway or to confirm a location within the nasal or sinus system,remove the light-fiber or fiber bundle while leaving the body portion ofdevice 1300 in place, and then use the lumen of device 1300 to guideother devices to a desired location. Alternatively, or in addition, thelumen of device 1300 could be attached to a vacuum source or a fluidcould be directed through the lumen 1300 (thereby allowing apractitioner to apply suction or deliver water and/or a medicament to adesired location within a sinus system before, during, or after use ofthe light-fiber or fiber bundle). In a further example, the light-fiberor fiber bundle can be removed while leaving the remainder of device1300 in a desired or confirmed location, thereby providing a visualguide along side of which a practitioner can guide other devices (e.g.,a balloon dilation device) to the desired or confirmed location. In someembodiments, the invention includes a removable light-fiber or fiberbundle that includes an atraumatic tip (e.g., a spherical ball tip).

In some embodiments, device 1300 may be attached or connected to a lightsource at proximal end 1308 and the light source directs light into andthrough the fiber bundle in lumen 1312 and out distal tip 1310. Distaltip 1310 can include an atraumatic tip (as best illustrated in FIG. 13).The specific size and dimensions of the lighted probe can be varied inorder to adapt the device for specific indications or uses. FIG. 15illustrates some of the dimensions of lighted probe 1300, includingoverall length L₁; lengths L₂, L₃, L₄, and L₅; angle α, and radius ofcurvature R.

The below Table 1 lists the numeric range of values that thosedimensions can take depending upon the specific design parameters for agiven embodiment of a lighted probe.

TABLE 1 Dimension Quantitative Value Length L₁ ~6 to ~8.5 inches LengthL₂ ~1.5 to ~4 inches Length L₃ ~0.750 to ~3 inches Length L₄ ~0.1 to~1.2 inches Length L₅ ~0.170 to ~0.250 inches Angle α ~0 to ~120 degreesRadius of curvature R 0.125 and 0.850 inches

In some embodiments of the invention, the lighted probe is sized anddimensioned to match or access the frontal sinus outflow tract orfrontal recess of a typical patient population, while in otherembodiments the probe is sized and dimensioned to match or access themaxillary and/or sphenoid sinus outflow tracts and/or cavities. Forexample, a lighted probe having an Angle α of about zero degrees(essentially a straight probe) would be particularly useful foraccessing the sphenoid sinus spaces. In some preferred embodiments,angle α is in a range of from about 28 degrees to about 88 degrees whilethe other dimensions angle α fall within the ranges listed in Table 1.In an especially preferred embodiment, length L₁ is about 7.067 inches,length L₂ is about 2.777 inches, length L₃ is about 1.930 inches, lengthL₄ is about 0.639 inches, length L₅ is about 0.210 inches, an angle α isabout 58 degrees, and a radius of curvature R of about 0.850 inches. Inanother especially preferred embodiment, length L₁ is about 6.886inches, length L₂ is about 2.616 inches, length L₃ is about 1.931inches, length L₄ is about 0.763 inches, length L₅ is about 0.210inches, an angle α is about 78 degrees, and a radius of curvature R ofabout 0.630 inches. In another especially preferred embodiment,particularly suited for use in the maxillary sinus cavities and outflowtract, angle α is between about 60 and about 120 degrees, the radius ofcurvature R is between 0.125 and 0.50 inches, and length L₄ is betweenabout 0.150 and 0.750 inches.

In some embodiments, the atraumatic ball tip of distal tip 1310 has adiameter in the range of between about 0.5 millimeters to about 2.5millimeters, while in some specific embodiments the atraumatic ball tiphas as diameter of about 0.060 inches.

In some embodiments, probe member 1304 has an inner wall diameter ofbetween 0.0195 inches and 0.0225 inches and an outer wall diameter ofbetween 0.1089 inches and 0.1092 inches. In some embodiments, the distalportion of probe member 1304 has an outer wall diameter that tapersgradually to a narrowed distal tip.

Prior or after use, the lighted probe can be sterilized via autoclaving,EtOH sterilization, or gamma irradiation.

In some embodiments, the invention includes the use of a light sourcehaving a distal portion that can be detached. FIG. 17 illustrates suchan embodiment as light source 1700. Light source 1700 includes handleportion 1702 and detachable distal portion 1704. In some embodiments,one of the two portions (e.g., the handle portion) can be made ofrelatively resilient materials so that it can be sterilized and reusedmany times while the other portion is made of more economical materialsso that it can be disposed of after one use. In further embodiments, thehandle portion can be made to accommodate a wide variety of differentsecond portions (e.g., differently shaped detachable distal portions).

Frequently, whenever two light-conducting elements join at a juncture,heat is generated when light crosses the juncture due to imperfectionsin the juncture. This is especially true when the juncture is betweenlight-conducting elements made of disparate materials (e.g., one made ofglass fiber and a second made of a polymeric fiber). In some cases, theheat generated can be quite substantial and can damage thelight-conducting elements or burn an operator. In some embodiments, thisinvention includes a connector used to connect a light source of theinvention with a light cable. The connector provides a juncture betweenthe light source and the light cable that can reduce the amount of heatgenerated, and/or dissipates generated heat, more effectively and safelythan if the light source and light cable were joined without theconnector.

FIG. 18 illustrates such an embodiment as connector 1800. Connector 1800can be attached on one side to light cable 1802 to form juncture 1806and on the other side to proximal end 1804 of the light fiber or fiberbundle of a light source of the invention to form juncture 1808 (forclarity, only the fiber bundle of a light source of the invention isillustrated in FIG. 18). Connector 1800 includes housing 1810 that canbe formed of a material that dissipates heat quickly (e.g., aluminum).Housing 1810 defines an inner lumen portion that contains alight-conducting element 1812 (e.g., a glass fiber or fiber bundle) andlight taper 1814. Light taper 1814, together with light cable 1802,forms juncture 1806. Light-conducting element 1812, together withproximal end 1804, forms junction 1808.

In use, light is transmitted across junction 1806 from light cable 1802to light taper 1814, where it is concentrated and focused into glassfiber 1812. The light then travels along glass fiber 1812, acrossjunction 1806, and into proximal end 1804. While some amount of heat maybe generated at junctions 1806 and 1808, the heat is easily dissipatedby housing 1810, thereby preventing a undesirable amount of heat frombuilding up in the assembly components.

FIGS. 19A-19C illustrate various aspects of an embodiment of theinvention that includes a light source device that have a removablelight-fiber 1900 and guide catheter 1902.

Guide catheter 1902 includes hypotube 1906 having malleable distal end1904 and rigid proximal portion 1910. Hypotube 1906 extends throughhandle 1908, with malleable distal end 1904 and a portion of rigidproximal portion 1910 extending from distal end 1912 of handle 1908.Hypotube 1906 defines a lumen extending from proximal portion 1914 todistal tip of malleable distal end 1904. Second proximal portion 1916defines a second lumen that joins together and is in fluid communicationwith the lumen defined by hypotube 1906.

Removable light-fiber 1900 is illustrated in FIGS. 19B and 19C, withportions of the length of light-fiber 1900 omitted from FIG. 19C forclarity. Light-fiber 1900 includes a length of single light-conductingfiber 1920 that extends from distal tip 1922 to proximal light connector1924. A proximal portion of light-fiber 1900 includes protective sheath1926 of polymeric material overlying light-fiber 1920 and protectivesheath 1928 of polymeric or metallic material overlying a proximalportion of protective sheath 1926. FIG. 19B also illustrates tuohy-borstconnector 1930.

In use, distal tip 1922 of light-fiber 1900 is directed into proximalportion 1914 of catheter 1902, through the lumen defined by hypotube1906, and to the distal tip of malleable distal end 1904. A light sourceis connected to proximal light connector 1924 so that light is conductedalong light-fiber 1920 and projected out from distal tip 1922.Light-fiber 1900 can be secured to catheter 1902 using connector 1930.In this way, the light conducting light-fiber 1900 is mounted withincatheter 1902 such that the light from distal tip 1922 emanates from thedistal end of catheter 1902. Once assembled to light-fiber 1900,catheter 1902 can be used to probe a sinus system and confirm, viatransdermal illumination, when the position of the distal end ofcatheter 1902 is within a maxillary or frontal sinus structure. Catheter1902 can also be used light a flashlight to illuminate sinus structuresfor viewing structures within the sinus system with an endoscope. Onceviewing or transdermal confirmation has been completed, a user maywithdraw both catheter 1902 and light-fiber 1900 from the sinus systemor, alternatively, may remove light-fiber 1900 leaving catheter 1902within the sinus system. Fluid (e.g., saline) or suction sources may besecured to second proximal portion 1916 in order to direct fluid fromthe distal end of malleable distal end 1904 or suction material into andthrough catheter 1902.

In some embodiments of the invention, a portable light source may beused and attached to the light-conducting devices described herein(e.g., device 1300 or light-fiber 1900). The portable light source mayinclude a battery-powered LED light source.

In some embodiments of the invention, light of various wavelengths maybe directed through the light-conducting devices described herein (e.g.,device 1300 or light-fiber 1900). Red or infrared light tends to passthrough blood and tissue more easily than light of other spectrums, souse of red light can be desirable when performing transdermalillumination. Hence, in some embodiments of the invention, a red lightmay be used with the light-conducting devices described herein when thedevices are used to illuminate transdermally while a white light may beused when the devices are used to view structures with an endoscope. Insome embodiments of the invention, a portable light source having twodissimilar colors of light (e.g., white and red) is used with thelight-conducting devices described herein, with the user toggling thelight source between the two colors as desired during use.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. The invention, therefore, should not belimited, except to the following claims, and their equivalents.

What is claimed is:
 1. A catheter device for illuminating sinusstructures comprising: a handle having a proximal end and a distal end,the handle configured to be gripped by an operator; a hypotube securedto the distal end of the handle, wherein the hypotube includes amalleable distal end extending distally from the handle, wherein themalleable distal end of the hypotube is shaped into a straight or curvedshape having an angle α within a range of 0 to 120 degrees, wherein thehypotube includes a rigid proximal end extending into the handle,wherein the hypotube defines a lumen from the rigid proximal end to adistal tip of the malleable distal end, and wherein the hypotube has alength extending from the distal end of the handle within a range ofabout 1.5 inches to about 4 inches; a removable light-fiber comprising alength of light-conducting fiber that extends from a distal tip to aproximal light connector, wherein the distal tip of the removablelight-fiber is positioned through an opening in the proximal end of thehandle, through the lumen defined by the hypotube, and to the distal tipof the malleable distal end of the hypotube; and wherein the removablelight-fiber is secured relative to the catheter device so that thehandle and removable light-fiber move together in tandem.
 2. Thecatheter device of claim 1, wherein, an inner diameter of the lumen ofthe hypotube is within a range of about 0.019 inch to about 0.050 inch.3. The catheter device of claim 1, wherein an inner diameter of thelumen of the hypotube is within a range of about 0.036 inch and about0.040 inch.
 4. The catheter device of claim 1, wherein the removablelight-fiber is secured relative to the handle via a connector.
 5. Thecatheter device of claim 1, wherein a proximal portion of the removablelight-fiber comprises a protective sheath.
 6. The catheter device ofclaim 1, wherein the removable light-fiber is positioned adjacent to thedistal tip of the malleable distal end of the hypotube such that lightemitted from the removable light-fiber emanates from the distal tip ofthe hypotube.
 7. The catheter device of claim 1, further comprising alight source connected to the proximal light connector.
 8. The catheterdevice of claim 7, wherein the light source comprises a white lightsource.
 9. The catheter device of claim 7, wherein the light sourcecomprises a red light source.
 10. The catheter device of claim 1,wherein the proximal light connector is formed from a heat dissipatingmaterial.
 11. The catheter device of claim 1, wherein the distal tip ofthe removable light-fiber comprises an atraumatic tip.
 12. The catheterdevice of claim 1, wherein the distal tip of the removable light-fibercomprises a curved surface.
 13. A method of using the catheter device ofclaim 1 comprising: advancing both the catheter device and light-fibertransnasally while grasping the handle to place the distal tip of themalleable distal end of the hypotube adjacent to a space or body lumenin a sinus passageway; emitting light from the light-fiber; and viewinga transdermal or transcutaneous illumination pattern to confirm properplacement of the catheter device.
 14. The method of claim 13, furthercomprising repositioning the catheter device and light-fiber.
 15. Themethod of claim 14, wherein repositioning comprises advancing thecatheter device and light-fiber distally.
 16. The method of claim 14,wherein repositioning comprises rotating the catheter device andlight-fiber.
 17. The catheter device of claim 1, wherein the malleabledistal end of the hypotube is shaped into a curved shape.
 18. Thecatheter device of claim 17, wherein the angle α is within a range ofabout 28 degrees to about 88 degrees.
 19. The catheter device of claim17, wherein the angle α is within a range of about 60 degrees to about120 degrees.